Goodwin is based in the USA (Florida) and has 30 years of recombinant protein, antibody, bioconjugates, and exosome manufacturing experience. We are FDA registered (including PAI approval), worked with over 150 clients on almost 500 different products (Ph-I/II/III) and helped file over 45 INDs. We are at the cusp of launching a number of commercial programs, and have implemented an expansion to address this increase demand.
The following are some of our core competencies:
• Proof of Concept and Early-Stage development support
• Cell line development with our strategic partners
• Bioprocess Development, Scale-up, and Purification
• Analytical Method Development and Qualification/Validation
• GMP Cell Banking
• Manufacturing for In-vivo and in-vitro Testing and Pre-clinical Studies
• Manufacturing of Toxicology and GMP Clinical Trial Supplies*
• Aseptic Fill and Finish
• QC Release and Stability Testing
• QA and CMC Support
* In the process of building our commercial manufacturing capabilities that will be ready in 2022.